EUCTR2006-006886-18-AT进行中（未招募）不适用
Efficacy and Safety of Vivitrol® in Adults Completing Inpatient Treatment for Alcohol Dependence - ALK21-014
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Alkermes Inc
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Capable of understanding and complying with the protocol, and has signed the informed consent document
- •Current diagnosis of alcohol dependence, meeting at least 5 of the DSM-IV criteria
- •18 years of age or older
- •Must be expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization
- •Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose
- •Must be free of symptoms and/or signs of acute alcohol withdrawal on the day of randomization
- •Must have a non-custodial stable residence and a telephone, plus one contact with verifiable address and telephone number
- •Must have a negative urine toxicological screen for opioids and benzodiazepines on the day of randomization
- •If subject is female and of child-bearing potential, she must agree to use an acceptable method of contraception for the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding
- •Clinically significant medical condition or observed abnormalities (including: physical examination, ECG, laboratory evaluation, and/or urinalysis findings)
- •Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal and/or esophageal variceal disease
- •Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
- •History of pancreatitis
- •Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the subject’s ability to complete the study.
- •Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM IV criteria
- •Current seizure disorder
- •Current eating disorder
- •Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period
- •Use of oral naltrexone, acamprosate, or disulfiram within 30 days prior to screening
- •Use of any excluded medication at screening or anticipated/required use during the study period
- •Receipt of any approved or investigational depot product administered into the gluteal muscle within 6 months of screening
- •Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
- •Previous enrollment in a Vivitrol (or Medisorb® Naltrexone) clinical trial
- •Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG
- •Any finding that in the view of the Principal Investigator would compromise the subject’s ability to fulfill the protocol visit schedule or visit requirements.
- •Subjects on parole or probation, or those with pending legal proceedings that have the potential for incarceration during the study period
研究者
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